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Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus

白内障超声乳化术对2型糖尿病患者角膜内皮细胞的影响 Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03260673
Enrollment
30
Registered
2017-08-24
Start date
2015-09-01
Completion date
2016-07-30
Last updated
2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Diabetes Mellitus

Keywords

cataract, phacoemulsification, type 2 diabetes mellitus, corneal endothelial cells

Brief summary

This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Detailed description

The investigators do the clinical prospective study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.Then, the investigators compared the two sets of data. At last observing the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Interventions

OTHERspecular microscope

The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
58 Years to 86 Years
Healthy volunteers
No

Inclusion criteria

the experimental group: 1. Clinical diagnosis of cataract 2. Type 2 diabetes mellitus 3. The recent blood glucose control was stable 4. The glycosylated hemoglobin \< 8% The control group: 1. Clinical diagnosis of cataract 2. No history of type 2 diabetes

Exclusion criteria

1. Corneal lesions 2. Anterior inflammation 3. Ocular trauma or surgical history 4. Glaucoma 5. Corneal endothelial cell density \< 1500 / mm squared

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the corneal endothelial cell density before-after cataract surgeryhalf yearComparison of the corneal endothelial cell density before-after cataract surgery,the density is expressed in terms of the number of cells per square millimeter.

Secondary

MeasureTime frameDescription
Comparison of the endothelial cell size before-after cataract surgeryhalf yearComparison of the endothelial cell size before-after cataract surgery,the size is measured in square microns.
Comparison of the percentage of hexagonal cells before-after cataract surgeryhalf yearComparison of the percentage of hexagonal cells before-after cataract surgery,the percentage are expressed as %.
Comparison of the central corneal thickness(CCT) before-after cataract surgeryhalf yearComparison of the central corneal thickness(CCT) before-after cataract surgery,the thickness is in microns.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026